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Zioptan

Generic name: tafluprost ophthalmic
Drug class: Ophthalmic glaucoma agents

Medically reviewed by  A Ras MD.

What is Zioptan used for?

Zioptan is a prescription medicine that tis  used to treat glaucoma. It is used to lower high eye pressure.

Description

Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R2R3R5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.53.

Its structural formula is:

Structural Formula

Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water.

ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmo/kg.

ZIOPTAN® contains Active: tafluprost 0.015 mg/mL; Inactives: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection.

ZIOPTAN® does not contain a preservative.

 Mechanism of Action

Tafluprost acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Before taking Zioptan, tell your doctor:

  • If you are allergic to Zioptan; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If the patient is a child. Do not give Zioptan to a child.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zioptan with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Zioptan?

  • Tell all of your health care providers that you take Zioptan. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Have your eye pressure checked. Talk with your doctor.
  • Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
  • If you have asthma, use Zioptan with care. Worsening of asthma has happened in people using Zioptan. Call your doctor right away if your asthma gets worse while you use Zioptan.
  • Use birth control that you can trust to prevent pregnancy while taking Zioptan.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Zioptan best taken?

Use Zioptan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • For the eye only.
  • Use in the evening.
  • Wash your hands before and after use.
  • Use right after opening.
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
  • Throw away any unused portion.
  • Blot extra solution from the eyelid.
  • If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
  • Use as you have been told, even if your signs get better.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.

What are the side effects of Zioptan that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Shortness of breath.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Eye discharge.
  • Eyelid problems.
  • Eye color may change to a brown color. This change may be long-lasting. Eye color changes may happen a few months to years after starting Zioptan. If eye color changes, call the doctor.

What are some other side effects of Zioptan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Stinging.
  • Itching.
  • Eye redness.
  • Eye irritation.
  • Blurred eyesight.
  • Eyelash growth.
  • Cough.
  • Signs of a common cold.
  • Dry eyes.
  • Headache.
  • This medicine may cause eyelash changes like dark eyelashes, thickness, or more eyelashes. Most of the time, these changes go back to normal after Zioptan is stopped.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Zioptan?

  • Store unopened foil pouch in the refrigerator.
  • Do not freeze.
  • Once foil pouch is open, keep drug in the foil pouch at room temperature for up to 30 days.
  • Throw away any unused portion after 30 days.
  • If you get Zioptan through mail-order: This medicine is often shipped in refrigerated packaging. If you get Zioptan more than 2 days after the date on the drug label and it was not shipped in refrigerated packaging or it is no longer cold, call the mail-order pharmacy. You may not be able to use it.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

Principal Display Panel Text for pouch Label:

  • NDC 17478-609-01
  • ZIOPTAN®
  • (tafluprost ophthalmic
  • solution) 0.0015%
  • For Topical Application in the Eye
  • Single-use Containers
  • Preservative-Free, Sterile
Principal Display Panel Text for pouch Label

 

Principal Display Panel Text for Carton Label:

  • NDC 17478-609-30
  • ZIOPTAN®
  • (tafluprost ophthalmic
  • solution)
  • 0.0015%
  • For Topical Application in the Eye
  • REFRIGERATE (2° to 8°C or 36° to 46°F)
  • Single-use Containers
  • Preservative-Free, Sterile
  • Contains:
  • Active: Tafluprost 0.0015%
  • (4.5 mcg per single-use container).
  • Inactive ingredients: Glycerol, Sodium Dihydrogen
  • Phosphate Dihydrate, Disodium Edetate, Polysorbate 80,
  • Water for Injection, Hydrochloric Acid and/or Sodium
  • Hydroxide are added to adjust pH.
  • Rx only
  • 30 Single-use Containers:
  • 3 pouches x 10 single-use containers
  • (0.3 mL each)
Principal Display Panel Text for Carton Label

SRC: NLM .

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